Summary Information to Help you Decide Whether to Join this Study

INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY

Study Title	EFF-6149 Desktop Consent Test — DO NOT ENROLL
Study Author	Matthew Amsden
Sponsor	No sponsor is listed. This is a disposable software-verification draft. There is no payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	No products or services are included.
Outcome Measures	Software outcomes: consent remains locked when background is missing; unlocks with all 13 saved items; saves and reads back generated consent. No clinical outcome data.
Contact	help@efforia.com

Introduction & Summary

Welcome to this draft on the Efforia platform. This document was created only to test Efforia’s desktop informed-consent software. No research participants will be recruited or enrolled. Only an adult Efforia staff tester may review the generated draft.

The purpose is to verify that consent stays unavailable until all required background items have been saved. The test also checks whether the production prompt can generate a draft that can be saved and reopened. There is no health claim, clinical treatment, product, service, payment, randomization, or clinical assessment.

The illustrative schedule lasts seven days and contains one private-reflection task on Day 1. The task is only for schedule-rendering verification. Testers must not enter personal or health information. No clinical outcome data will be collected.

Review of this draft is voluntary. A staff tester may stop at any time without penalty. Ask questions and resolve any concerns before continuing. Creating or reviewing this draft does not approve or publish it.

Purpose of the Study

This software test is being conducted to check the desktop informed-consent workflow against production application programming interfaces. An application programming interface is a tool that allows software systems to exchange information.

The test has three software goals:

• Confirm that consent remains locked when required background information is missing.
• Confirm that consent unlocks after all 13 required background items are saved.
• Confirm that generated consent can be saved and read back after a request.

The only listed measure is a set of software outcomes. These are checks of the consent software, not measures of a person’s health. The test will not use statistical inference or participant analysis. Staff may compare saved consent content before and after software requests.

The illustrative activity is called a “private reflection.” For this test, that means a single entry shown on the Day 1 schedule at any time. No content requirements are specified. It is not a treatment, health assessment, or therapeutic activity. Testers must not put personal or health information in the entry.

No products are associated with this test. Product ingredients, product descriptions, treatments, clinical services, and health devices do not apply.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

For clarity, this draft does not permit actual participant enrollment. There is no payment, shipping, identity verification, product order, or clinical participation. Only an adult Efforia staff tester may review the software workflow.

The Risks, Discomforts & Benefits of Being in this Study

There are risks, discomforts, and possible benefits that should be understood before reviewing a research workflow. This disposable software test does not include a clinical intervention. Its known risks are limited to minor inconvenience and possible disclosure if a tester enters personal information against the instructions.

Consider your Own Risk-Benefit Comfort Level

You should weigh the risks and possible benefits before taking part in any research. Efforia’s model may place more responsibility on a person to decide whether a study is right for them than a traditionally sponsored trial. This draft, however, is not open for enrollment and is not a pay-to-participate trial.

It is possible that not all risks and benefits are currently known.

Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study.

No one should enroll in this software test. Medical consultation is not required merely to review the software as an adult Efforia staff tester because no health intervention is involved.

Personal and Overall Findings

This test will not produce personal health outcomes or overall clinical findings. It may produce software-verification findings, such as whether the consent stayed locked, unlocked after all required items were saved, and could be saved and reopened.

In studies that collect participant outcomes, Efforia may show participants their personal results and pooled findings at data-collection points or as findings become available. New information may affect a person’s willingness to remain in a study. Participation in an enrollment study would be voluntary, and a participant could leave by contacting help@efforia.com. Those general statements do not change the instruction that no one may enroll in this test.

Possible Benefits of Participation

There is no expected health or therapeutic benefit. Staff review may help identify software problems in the consent workflow. No payment is required, and there is no intervention or treatment.

Participation in research may provide no benefit. Payment does not guarantee any benefit from an intervention or treatment. In this test, the cost is $0 and no intervention or treatment is offered. There may be no measurable benefit to the tester other than seeing that the software did or did not work as expected.

Possible Serious Adverse Events & Side Effects

No products, clinical intervention, or actual participant enrollment are part of this disposable software test. The illustrative private-reflection task could involve minor inconvenience or inadvertent disclosure if someone entered personal information; testers must not enter personal or health data. No therapeutic benefit, product safety claim, or ethics approval is established.

Privacy & Security Risks

Efforia uses measures intended to keep data private and confidential. However, no system can be guaranteed to have no risk. Possible risks include unauthorized access, account compromise, accidental disclosure, or a notification being seen by another person.

Review the Efforia privacy policy before using the platform: https://efforia.com/privacy-policy/.

There may be limits to privacy. Efforia may contact local emergency help if it has reason to believe that you may harm yourself or another person. Regulators, such as the United States Food and Drug Administration or a similar agency, and an Institutional Review Board may be allowed to review identifiable research records when applicable. No regulatory or ethics review approval has been established for this software test.

What to do if you have a study related injury.

If you believe you have a study-related injury, seek appropriate local medical care first. Efforia cannot provide emergency medical care or make a diagnosis.

After you receive any needed care, contact Efforia if you experience a problem, side effect, or possible study-related injury. Reporting a problem may help Efforia warn others about possible risks. This software test has no treatment or product, but unexpected problems should still be reported.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

Alternatives to Participating in the Study

This is for software-verification research only. The alternative is not to take part. No one should enroll in this disposable test.

If another Efforia study does not seem right for your needs or is too expensive, you may select the Efforia logo near the top of the page to look for another study. Review the risks, costs, eligibility rules, and consent information for any other study before deciding whether to join.

Your Rights as a Participant:

Ethical Considerations: Efforia states that it seeks to uphold high ethical standards while hosting studies. Hosting a study is different from sponsoring or conducting it. Participation in any valid research study must be voluntary. You may withdraw without adverse consequences, and signing a consent form does not mean that you give up legal rights.

This software fixture is not approved for participant enrollment. Only adult Efforia staff testers may review it.

Privacy and Confidentiality

You have a right to privacy and confidentiality in research. Personal information should be protected through appropriate security and access controls. Data processing should be designed to reduce unauthorized access, disclosure, alteration, and misuse. No security measure can remove every risk.

Right to Your Own Results

Participants in a research study may have a right to an explanation of the research after their involvement ends, especially if the study used deception, a placebo, or a control group. This software test uses none of these methods and produces no personal health results.

The Right to Leave a Study without Penalty at Any time

In an enrollment study, you may leave by visiting your Profile page, selecting “Your Protocols,” and clicking “Leave.” You may also contact help@efforia.com. Any refund for products would depend on whether consumable products were shipped and whether returned non-consumable products meet the applicable return policy.

This test costs $0 and has no products, orders, shipments, or refunds. A staff tester may stop reviewing it at any time.

Conflict of Interest Statement

Transparency about sponsorship and financial interests is important in citizen science and clinical research. This disposable fixture is not a clinical trial, is not sponsored by participants, and has no participant payment. No sponsor is listed in the saved trial record.

Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia generally may take a transaction fee on products and services included in a protocol. This test includes no products or services and costs $0, so there is no product or service transaction fee for this test. No other financial interest or conflict of interest is identified in the saved record.

To reduce pressure to enroll, Efforia may send one reminder if someone does not complete enrollment in a study. Efforia states that it will not remarket the study or otherwise push the person to join. No enrollment reminder should be used to recruit anyone into this disposable test.

How we Reduce Conflicts of Interest:

Participants also have a role in reducing conflicts of interest. A person should disclose any financial relationship with an intervention provider or measurement provider used in a trial. Employees, investors, stakeholders, and protocol authors connected with those providers may have conflicts that could affect the study’s integrity or results.

This test has no intervention provider or measurement provider. The only permitted reviewers are adult Efforia staff testers, so their staff role is expected and should be documented as part of the software test.

Consequences of Conflict of Interest Non-Compliance:

In a participant study, failure to disclose a required conflict of interest or a breach of the conflict policy may result in immediate suspension from the platform. Payments may not be refunded when allowed by the applicable terms and law. This test has no participant payment.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

This required general statement does not authorize enrollment in this test. Do not join or enroll.

Data Protections:

The software test may record or display workflow information needed to confirm whether required background items were saved, whether consent became available, and whether generated content could be saved and reopened. It is not designed to collect health information or clinical outcome data.

Testers must not enter personal or health information into the private-reflection task. Access should be limited to authorized people who need it for software verification. Efforia should use reasonable administrative, technical, and organizational safeguards and handle data under applicable data-protection laws and its privacy policy.

Data should be kept only as long as needed for the software-verification purpose or as required by law and applicable records policies. No promise of complete security or anonymity can be made.

What you can do to improve your privacy and security:

As part of participating in an Efforia study, you may receive notifications by email, text message, or push notification when tasks, questionnaires, or reminders are ready. You can change communication preferences in the Efforia application. If you do not want study notifications, do not press the Accept button and do not join the study.

To prevent others from seeing alerts, protect your phone, computer, and email accounts with a password, personal identification number, or another access control. Do not share your accounts or passwords. Learn more about privacy and security rights at https://efforia.com/privacy-policy/.

Who will have access to your data?

Authorized Efforia personnel may have access to data needed to operate the platform and verify the software. Some Efforia studies may involve partners, such as laboratories or connected health-device providers, that receive data needed for their services. This software test has no laboratory, connected health device, product, or outside service listed.

What will we do with your data

In studies that collect outcomes, Efforia may use data to show participants personal results and combine results with those of other participants to report general outcomes. Efforia states that it will not use information linked to a person’s name or other identifying details without permission, except as described in the consent, privacy policy, or required by law.

This test will not produce personal health results or pooled clinical outcomes. Its data use is limited to checking the consent workflow and comparing saved consent content before and after software requests.

California Experiential Research Subject’s Bill of Rights:

California law provides a California Experimental Subject’s Bill of Rights for people asked to take part in certain medical experiments. These rights generally include being told the purpose, procedures, risks, possible benefits, and alternatives; being allowed to ask questions; being told whom to contact; receiving a copy of the signed consent form; and choosing not to participate or to stop without loss of benefits to which the person is otherwise entitled.

This disposable software test is not a medical experiment and is not open for participant enrollment. California residents may review Efforia’s privacy practices at https://efforia.com/privacy-policy/.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study-related injury, contact:
HELP@EFFORIA.COM
(646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please go to the nearest emergency room.
If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact Univo IRB at (919) 910-7743 or via email at info@univo-group.com.
Univo IRB
4509 Creedmoor Road Suite 403
Raleigh, NC 27612
info@univo-group.com
(919) 910-7743

No ethics approval is established in the saved record for this disposable software test. Listing contact information does not show that Univo IRB or any other Institutional Review Board reviewed or approved this draft.

Additional questions and closing

You must consider the information in a valid consent form for yourself before deciding whether to join any research study. For this disposable software test, no one may enroll. Only an adult Efforia staff tester may review the generated draft.

If you have questions, please contact help@efforia.com. For a health-related study, it is up to you to do additional research and talk to your physician before joining.